Download pdf - Precautionsin Handling of Prefilled SyringesCase 2) The prefilled syringe’s gasket was distorted, so the drug solution leaked out from the opening between the syringe barrel and

■ No.17 May, 2010Medical Safety Information Pharmaceuticals and Medical Devices Agency http://www.pmda.go.jp/english/service/medical_info.html

During administration of dopamine via a syringe pump, a pre-filled syringe’s plunger came off from the gasket, and the drug solution ended up being injected too fast to a patient.

Precautions when using prefilled syringes (Part 1) 1

Gasket

Plunger

When being set to a syringe pump, the loosening of connection of the plunger and gasket and the height difference may cause fast injection speed.

A prefilled syringe’s plunger is screwed into the gasket and connected together. The connection may become loose during use, so be very careful.

The plunger and gasket came off!

(Case 1)

Height difference

Drug solution injected too fast!

Syringe pump

Key points for safe use

Precautions in Handling of Prefilled Syringes

No. 17, May 2010


(Case 2) The prefilled syringe’s gasket was distorted, so the drug solution leaked out from the opening between the syringe barrel and the gasket.

Precautions when using prefilled syringes (Part 2) 2When assembling a prefilled syringe, make sure to screw in the plunger by rotating it.

Gasket

Syringe barrel

The gasket gets distorted by being pushed by the plunger

Plunger

Do not push in!

Distortion of gasket may cause drug solution leakage and air bubble entry. When assembling a prefilled syringe, do it correctly following the instructions on the Package Insert, etc.

DOBUPUM Injection 0.3% syringe

INOVAN Injection 0.1% syringe

Prefilled syringes that are assembled for use.

Kyowa Hakko Kirin Co., Ltd.

INOVAN Injection 0.6% syringe INOVAN Injection 0.3% syringe

Terumo Corporation

DOBUPUM Injection 0.1% syringe DOBUPUM Injection 0.6% syringe


Nitorol Injection for Continuous Infusion 25mg Syringe

1% Diprivan Injection-kit (200mg 20mL cylinder）

AstraZeneca K.K. Eisai Co., Ltd.

1% Diprivan Injection-kit (500mg 50mL cylinder）

Screw in the plunger by rotating it.

Prefilled syringes that have already been assembled

Ajinomoto Pharmaceuticals Co., Ltd.

LOWHEPA 100 U/mL SYRINGE 20mL



Even a prefilled syringe that has already been assembledmay become loose during handling, so be very careful.

Taiyo Yakuhin Co., Ltd.

Heparin Sodium 150 Units/mL “AT” 20 mL for Dialysis




HEPARIN SODIUM 500 units/mL for dialysis use

Nipro Pharma Corporation

HEPARIN SODIUM 500 units/mL for dialysis use

HEPAFILLED for Dialysis 250 Units/mL SYRINGE 20mL

Otsuka Pharmaceutical Factory, Inc.

When setting these heparin syringes to dialysis devices as well as syringe pumps, be careful that the plungers do not become disconnected from the gasket.

Fuso Pharmaceutical Industries, Ltd.

Heparin Sodium 150 Units/mL Syringe 20mL "Fuso" for Dialysis Heparin Sodium 200 Units/mL Syringe 20mL "Fuso" for Dialysis

Heparin Sodium 250 Units/mL Syringe 20mL “Fuso” for Dialysis Heparin Sodium 350 Units/mL Syringe 20mL “Fuso” for Dialysis

Nipro Pharma Corporation

ARGATROBAN INJECTION SYRINGE

About this information* PMDA Medical Safety Information is issued by the Pharmaceuticals and Medical Devices Agency for the purpose

of providing healthcare providers with clearer information from the perspective of promoting the safe use of pharmaceuticals and medical devices. The information presented here has been compiled, with the assistance of expert advice, from cases collected as Medical Accident Information Reports by the Japan Council for Quality Health Care, and collected as Adverse Drug Reaction and Malfunction Reports in accordance with the Pharmaceutical Affairs Law.

* We have tried to ensure the accuracy of this information at the time of its compilation but do not guarantee its accuracy in the future.

* This information is not intended to impose constraints on the discretion of healthcare professionals or to impose obligations and responsibility on them, but is provided as a support to promote the safe use of pharmaceuticals and medical devices by healthcare professionals.